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Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

China156 participantsStarted 2023-11-07

Plain-language summary

This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged 18 years and older.
✓. Subjects with coronary artery disease who have symptoms of angina pectoris and evidence of ischemia or myocardial viability in the area innervated by the coronary arteries where the CTO is located.
✓. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
✓. There is only one target CTO that needs to be treated with percutaneous coronary intervention (PCI).
✓. Target CTO is located in a native coronary artery with a reference vessel diameter of ≥ 2.5 mm.
✓. Angiography showed complete occlusion of the target CTO (visual inspection), antegrade flow of the occluded vessel segment TIMI grade 0 and inferred occlusion time ≥ 3 months; or previous angiographic records confirmed occluded time of the target CTO ≥ 3 months.
✓. The target CTO occluded segment length ≥ 5 mm (visual inspection).
✓. Angiography of the target CTO showed high density along the vessel, which is considered calcified lesion.

Exclusion criteria

✕. Acute myocardial infarction within 30 days prior to baseline procedure.
✕. Life expectancy \< 1 year.
✕. Inability to use protocol-required concomitant medications (eg, aspirin, P2Y12 platelet receptor inhibitors, heparin, contrast agents, etc) due to allergy or other contraindications, and no alternative medications.
✕. The target CTO has an iatrogenic dissection that occurred within the past 3 months.
✕. Left ventricular ejection fraction less than 35%.
✕. Severe aortic or mitral valve disease.
✕. Planned left ventricular (LV) support device during CTO PCI.
✕. Subjects with clear bleeding tendency, contraindications to antiplatelet agents and anticoagulant therapy.

What they're measuring

Device success

Timeframe: Baseline procedure

Trial details

NCT IDNCT05813704

SponsorShanghai MicroPort Rhythm MedTech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04

Contact for this trial

Tingting Wu, M.D.

0086-021-38954600 TingTing.Wu2@microport.com

View on ClinicalTrials.gov More Chronic Total Occlusion of Coronary Artery trials